Correlation Between Selenium Levels in Human Tissues and HPV-related Cervical Lesions and Outcomes

Not yet recruiting

• Conditions: Cervical Intraepithelial Neoplasia (CIN); Cervical Cancer; Persistent HPV Infection

• Registration Number: NCT06665841
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

This study investigates the relationship between selenium levels in human tissues and the persistence of HPV (human papillomavirus) infection, particularly focusing on cervical-related lesions. The main objectives are to explore the correlation between selenium levels in different body samples (hair, nails, urine, and blood) and to evaluate selenium's potential protective effects against HPV persistence and its progression to cervical lesions.

Key goals of the study include:

Determining whether non-invasive monitoring (e.g., hair, nails, urine) can accurately reflect blood selenium levels.

Understanding how selenium levels fluctuate in women with persistent HPV infection, and whether selenium supplementation can reduce the risk of HPV-related cervical disease progression.

Exploring selenium's role in enhancing immune function, especially in older adults, to help clear HPV infection.

By recruiting volunteers for selenium level testing and tracking HPV-positive women over time, this research aims to provide evidence on the effectiveness of selenium in preventing cervical cancer progression and potentially clearing HPV infections.

Detailed Description

This prospective study aims to explore the impact of selenium levels in human tissues on the progression of HPV-related cervical lesions and to identify the most appropriate biological samples for monitoring selenium levels. The research is divided into three parts:

Part 1: Volunteer Recruitment and Selenium Level Assessment Healthy volunteers, such as those undergoing regular medical check-ups or university students, will be recruited. Selenium levels in various biological samples-blood, hair (scalp or pubic), urine, and nails-will be measured. The primary goal is to assess the correlation between selenium levels in these different tissues to determine whether non-invasive samples (hair, nails, urine) could be used as reliable indicators of blood selenium levels.

Part 2: Patient Group Sample Collection Samples will be collected from hospitalized patients diagnosed with conditions such as uterine fibroids, cervical cancer, endometrial cancer, and ovarian cancer. These samples will include blood, hair (scalp or pubic), urine, and nails, with the same goal of determining the correlation between selenium levels in various tissues. This part of the study will help assess selenium levels in patients with reproductive system diseases and evaluate any differences compared to healthy individuals.

Part 3: HPV Persistent Infection Group Women with persistent HPV infection (defined as infection with the same HPV type for more than 12 months) will be selected from the gynecology clinic, along with a control group of women with non-persistent HPV infection. Selenium levels and immune function will be evaluated at baseline and again after 12 months. Comparisons will be made between the two groups to assess changes in selenium levels and immune function. Additionally, patients with HPV-related cervical lesions (e.g., CIN or cervical cancer) and those with normal cervical tissues will have their serum selenium levels and immune function assessed.

This part of the study will also include the collection of blood, hair (scalp or pubic), urine, and nail samples from HPV-persistent patients. These patients will be divided into three groups: (1) no treatment, (2) interferon treatment (standard clinical practice), and (3) interferon combined with selenium supplementation. The patients will be monitored for 6 and 12 months to observe changes in HPV status (whether the infection clears or persists) and to analyze selenium levels, immune function, and disease progression in CIN I patients.

Selenium supplementation, provided in the form of nano-selenium capsules, will be administered based on the selenium status determined from the external lab results. Patients will be divided into three groups based on their selenium levels:

Normal selenium levels: 50 µg selenium supplement, taken twice daily. Selenium deficiency: 100 µg selenium supplement, taken twice daily. Severe selenium deficiency: 150 µg selenium supplement, taken twice daily. The study will employ various statistical methods, including correlation analysis, univariate and multivariate analysis, and variance analysis, to evaluate the results. The findings will help determine whether selenium supplementation can aid in HPV clearance, slow the progression of cervical lesions, and enhance immune function, particularly in selenium-deficient individuals.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2024-11-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Aged 18 to 65 years;
• No history of sexual activity within the past 3 days;
• No history of cervical surgery;
• No history of using contraceptives, hormone therapy, or exposure to metals;
• No history of cardiovascular, cerebrovascular, liver, kidney, or thyroid diseases;
• All participants must sign a written informed consent form prior to sampling and agree to cooperate with the study.

Exclusion Criteria

• Previous diagnosis of HPV positivity and those who have received treatment;
• Pregnant individuals;
• Individuals who refuse to cooperate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Selenium Level Assessment:	At enrollment, 6 months after enrollment, and 12 months after enrollment	Measurement of serum selenium content: Determined by atomic fluorescence spectrometry / inductively coupled plasma mass spectrometry.

Secondary Outcome Measures

Name	Time	Method
Immune Function Evaluation	At enrollment, 6 months after enrollment, and 12 months after enrollment	Complete blood count: White blood cell count, neutrophils, lymphocytes, monocytes, red blood cells, hemoglobin, platelets, CRP. Analysis of immune cells in peripheral blood (flow cytometry): B cells; T cells; NK cells; monocytes.
HPV and TCT Detection, and Definition of HPV Clearance	At enrollment, 6 months after enrollment, and 12 months after enrollment	HPV detection: Real-time quantitative PCR; TCT detection: Cervical cells are assessed using a liquid-based thin-layer cytology system and classified cytologically.; Definition of HPV clearance: * Ineffective: HPV subtype remains positive or increases other subtypes; ② Improvement: ≥1 HPV positive subtype becomes negative while still having HPV infection; ③ Complete clearance: All HPV subtypes become negative.